Evaluation of the Safety of C-Spine Clearance by Paramedics

The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.

Study Overview

• Status: Completed
• Conditions: Fracture of Cervical Spine
• Intervention / Treatment: Procedure: Canadian C-Spine Rule

• Study Type: Interventional
• Enrollment (Actual): 4034
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Ottawa Paramedic Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consecutive alert, stable adults evaluated by the paramedics with potential c-spine injury after sustaining acute blunt trauma. Patient eligibility will be determined at the time of paramedic arrival at the scene based on the following criteria:

• "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either:

  • neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck),
  • no neck pain but some visible injury above the clavicles, and/or
  • neither neck pain nor visible injury, but significant mechanism of injury as determined by the paramedic at the scene.
• "Alert" is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and follows commands).
• "Stable" refers to normal vital signs(systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute).
• "Acute" refers to injury within the past 4 hours.

Exclusion Criteria:

• Patients under the age of 16 years,
• Patients with penetrating trauma from stabbing or gunshot wound,
• Patients with acute paralysis (paraplegia, quadriplegia),
• Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or
• Patients referred from another hospital and transported between facilities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible low-risk trauma patients; Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.	Procedure: Canadian C-Spine Rule; Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Measures of safety will include: number of missed cervical spine injuries; number of serious adverse outcomes	within 30 days of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance Rate	Proportion of eligible low-risk patients transported without immobilization	Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
Performance of the Canadian C-Spine Rule	Measurements of the performance of the rule will include: rule accuracy; paramedic accuracy of interpretation; paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule	Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.
Scene Time	Time spent at scene (difference between Paramedic scene departure and arrival at patient side)	immediately following evaluation
Average Contact Time	Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)	immediately following evaluation

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Christian Vaillancourt, MD, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Vaillancourt C, Charette M, Kasaboski A, Maloney J, Wells GA, Stiell IG. Evaluation of the safety of C-spine clearance by paramedics: design and methodology. BMC Emerg Med. 2011 Feb 1;11:1. doi: 10.1186/1471-227X-11-1.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: spinal cord injury; Canadian C-Spine Rule; neck injury; cervical-spine injuries; cervical-spine fractures; paramedics; emergency medical services
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2009142-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No